RecruitingPhase 4NCT07438444
A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity
A Phase 4, Open-Label, Single-Arm, 46-Week Study to Investigate the Safety and Efficacy With Tirzepatide in Adult Indian Participants With Either Type 2 Diabetes or Obesity
Sponsor
Eli Lilly and Company
Enrollment
344 participants
Start Date
Feb 27, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- Participants with Type 2 Diabetes:
- Have had type 2 diabetes for at least one year
- Insulin naive
- Have HbA1c ≥7.5% and ≤10% at screening
- Have body mass index (BMI) ≥23 kilograms per square meter (kg/m2)
- Participants with Obesity or Overweight without Type 2 Diabetes:
- Have a BMI
- Greater than or equal to 30 kg/m2 OR
- Greater than or equal to 27 kg/m2 AND previously diagnosed with at least one of the following weight-related comorbidities: high blood pressure, lipid disorder, obstructive sleep apnea, heart disease
Exclusion Criteria18
- Participants with Type 2 Diabetes:
- Have type 1 diabetes
- Have had any of the following heart conditions within 6 months prior to screening:
- heart attack
- stroke
- hospitalization due to heart failure
- Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF)
- Have type 2 diabetes along with morbid obesity and being considered for bariatric surgery or any other procedure intended for weight loss
- Participants with Obesity or Overweight without Type 2 Diabetes:
- Have type 1 diabetes or type 2 diabetes
- Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity
- Have had any of the following heart conditions within 6 months prior to screening:
- heart attack
- stroke
- hospitalization due to heart failure
- Have New York Heart Association Functional Classification Class III or IV CHF
- Have taken any medications or alternative remedies for weight loss within 3 months prior to screening
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Interventions
DRUGTirzepatide
Administered SC
Locations(21)
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NCT07438444
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